cytiva Biacore X100 Operating Instructions Manual
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cytiva Biacore X100 Operating Instructions Manual

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Biacore™ X100
Operating Instructions
Original instructions
cytiva.com

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Summary of Contents for cytiva Biacore X100

  • Page 1 Biacore™ X100 Operating Instructions Original instructions cytiva.com...

  • Page 2: Table Of Contents

    Component maintenance .......................... 55 Replacing the mains fuses .......................... 56 Calibration ................................ 58 Storage ................................59 Troubleshooting ....................61 Instrument related problems ........................62 Other problems .............................. 66 Reference information ..................67 Specifications ..............................68 Biacore X100 Operating Instructions 28961142 AF...
  • Page 3 North America ............................... 78 8.4.6 China .................................. 79 8.4.7 General regulatory statements ......................82 8.4.8 Other regulations and standards ......................83 Ordering information ........................... 84 Health and Safety Declaration Form ...................... 85 Index ........................... 87 Biacore X100 Operating Instructions 28961142 AF...

  • Page 4: Introduction

    This chapter contains important user information, descriptions of safety notices, regu- latory information, intended use of the Biacore™ X100, and lists of associated docu- mentation. In this chapter Section See page Important user information About this manual Associated documentation Biacore X100 Operating Instructions 28961142 AF...

  • Page 5: Important User Information

    Intended use of the product Biacore X100 is a system for real-time label-free analysis of molecular interactions in laboratory research. Biacore X100 is intended for research use only and shall not be used for diagnostic purposes in any clinical or in vitro procedures.

  • Page 6: About This Manual

    Typographical conventions Software items are identified in the text by bold italic text. Hardware items are identified in the text by bold text. Tip: The text can include clickable hyperlinks to reference information. Biacore X100 Operating Instructions 28961142 AF...

  • Page 7: Associated Documentation

    Cytiva. User documentation The main components of the documentation for Biacore X100 are listed in the table below. Translations of the Biacore X100 Operating Instructions are provided in PDF format on the documentation CD inside the back cover of the printed Operating Instructions.

  • Page 8: Safety Instructions

    All users must read and understand the entire contents of this general safety chapter, and the specific safety precau- tions information in each subsequent chapter of this manual to become aware of the hazards involved. Biacore X100 Operating Instructions 28961142 AF...

  • Page 9: Safety Precautions

    2.1 Safety precautions Safety precautions Introduction Biacore X100 is powered by mains voltage and handles materials that can be hazardous. Before installing, operating or maintaining the system, you must be aware of the hazards described in this manual. Follow the instructions to avoid injury to the operator or other personnel, damage to samples or other substances handled by the equipment, to the product, or to other equipment in the area.
  • Page 10 Protective ground. The product must always be connected to a grounded power outlet. WARNING Use only mains cables supplied or approved by Cytiva. WARNING Do not block the rear or side panels of the instrument. The power switch must always be easy to access. The power cord must always be easy to disconnect.
  • Page 11 Personal protection WARNING Always wear appropriate protective clothing and equipment during operation and maintenance of the product. Use required safety equipment when handling hazardous substances. Biacore X100 Operating Instructions 28961142 AF...
  • Page 12 All lifting and moving must be performed in accordance with local regulations. CAUTION Make sure that hands or fingers are not trapped under the instru- ment when the instrument is lifted or moved. Biacore X100 Operating Instructions 28961142 AF...
  • Page 13 Make sure that the waste container has sufficient space for maximum waste volume when the equipment is left unattended. CAUTION Make sure that all fluidic tubes are secured and properly connected or sealed at both ends before, during and after operation. Biacore X100 Operating Instructions 28961142 AF...
  • Page 14 All service and repairs, with the exception of operations explicitly described in the user documentation, must be carried out by personnel authorized by Cytiva. Do not open any covers or replace any parts unless specifically stated in the user documentation.

  • Page 15: Labels

    Frequency Electrical rating: Frequency (Hz) Max Power Electrical rating: Maximum power (VA) Fuse rating Fuse rating: number of fuses, type T (slow acting), trip current (A), breaking capacity H (high), or maximum voltage (V) Biacore X100 Operating Instructions 28961142 AF...

  • Page 16: Emergency Procedures

    To stop a run under controlled conditions before it is complete, choose Run →Stop Run Sensorgram from the menu bar in Biacore X100 Control Software . This will stop both the run and the data collection at the end of the current cycle. A dialog is displayed while the current cycle is finished.
  • Page 17 Turn on mains power if it is switched off and check that the instrument starts normally. If you need to clean the liquid handling system, eject the sensor chip and insert a maintenance chip. See Section 6.3 Cleaning, on page 51 for further instructions. Biacore X100 Operating Instructions 28961142 AF...

  • Page 18: System Description

    3 System description System description About this chapter This chapter gives an overview of the Biacore X100 system, and a brief description of its function. In this chapter Section See page Biacore X100 instrument Indicators and switches Sensor chip Control system...

  • Page 19: Biacore X100 Instrument

    The main parts of the instrument are identified below. Part Function Status indicators Lower front door with pump compartment and optional degasser (included in Biacore X100 Plus Package) behind Buffer tubes Buffer bottle Buffer tray Upper front door with sensor chip port behind...
  • Page 20 If this happens, disconnect the instrument from the mains power and call your local service representative. CAUTION Waste tubes and containers shall be secured and sealed to prevent accidental spillage. Sample compartment Biacore X100 Operating Instructions 28961142 AF...
  • Page 21 Do not attempt to rotate the rack by hand in the instrument. Connections Connections for mains power and computer communication as illustrated below are on the rear of the instrument at the right hand side. SERVICE Part Function Computer ports Mains switch Biacore X100 Operating Instructions 28961142 AF...
  • Page 22 3 System description 3.1 Biacore X100 instrument Part Function Fuse compartment Mains inlet Note: For warning texts, see Section 6.5 Replacing the mains fuses, on page Biacore X100 Operating Instructions 28961142 AF...

  • Page 23: Indicators And Switches

    Lit when a run is in progress. Mains power switch The mains power connector and switch is located on the mains input panel, at the rear right of the instrument (see Connections, on page 21). Biacore X100 Operating Instructions 28961142 AF...

  • Page 24: Sensor Chip

    Do not remove the sensor chip from the cassette. The illustration below shows the sensor chip separate from the cassette for illustration purposes. Part Function Frame Gold-coated glass slide Cassette Biacore X100 Operating Instructions 28961142 AF...

  • Page 25: Control System

    Biacore X100 Evaluation Software is a stand-alone software for evaluation of results obtained from Biacore X100. The software is normally installed on the same computer as the Biacore X100 Control Software , although connection to the instrument is not required for using Biacore X100 Evaluation Software.

  • Page 26: Installation

    About this chapter This chapter describes site requirements and preparations necessary to perform before installation of the Biacore X100 system. In addition, instructions are included for moving the Biacore X100 system within the laboratory or to another building. NOTICE The product is prepared and installed by Cytiva personnel. Contact Cytiva if you require re-installation at a new site.

  • Page 27: Site Requirements

    PC beside the instrument. The laboratory bench must be stable and able to support the weight of the instrument. 200 mm 575 mm 200 mm 200 mm 530 mm 600 mm 200 mm Biacore X100 Operating Instructions 28961142 AF...
  • Page 28 Protective ground. The product must always be connected to a grounded power outlet. WARNING Use only mains cables supplied or approved by Cytiva. WARNING Do not block the rear or side panels of the instrument. The power switch must always be easy to access. The power cord must always be easy to disconnect.
  • Page 29 Pollution degree 2 ronment Avoid placing the system adjacent to heaters or air conditioners. Condensation may occur in the sample compartment at high ambient humidity. This is normal and does not indicate any malfunction. Biacore X100 Operating Instructions 28961142 AF...

  • Page 30: Unpacking, Assembly And Transport

    Biacore X100 requires no special assembly other than that performed by Cytiva personnel during installation. Transport To avoid damage, the optical unit in Biacore X100 must be secured before transport over more than limited distances within the laboratory. Contact Cytiva for assistance. CAUTION Heavy object.

  • Page 31: Connections

    Check that any mains voltage selectors on the PC and peripheral equipment are set correctly. Install the PC and peripheral equipment according to the respective instruc- tion manuals. Biacore X100 Operating Instructions 28961142 AF...
  • Page 32 4 Installation 4.3 Connections WARNING Do not block the rear or side panels of the instrument. The power switch must always be easy to access. The power cord must always be easy to disconnect. Biacore X100 Operating Instructions 28961142 AF...

  • Page 33: Operation

    Always wear appropriate protective clothing and equipment during operation and maintenance of the product. Use required safety equipment when handling hazardous substances. WARNING Do not use any accessories not supplied or recommended by Cytiva. Biacore X100 Operating Instructions 28961142 AF...
  • Page 34 CAUTION Waste tubes and containers shall be secured and sealed to prevent accidental spillage. CAUTION Accidental breakage of glass bottles may leave sharp fragments and splinters that can cause cuts and abrasions. Biacore X100 Operating Instructions 28961142 AF...

  • Page 35: Overview

    5 Operation 5.1 Overview Overview The typical workflow for performing a run in Biacore X100 is shown in the table below. Some analyses may require several runs to complete the experiment. Stage Description More information Create a workflow or Biacore X100 Handbook or soft-...

  • Page 36: Starting The Instrument

    Start the instrument from shutdown NOTICE If you have the Biacore X100 Plus Package, always keep the buffer tubes in liquid when the instrument is powered on to prolong the life of the degasser. Follow the steps below to start the system from shutdown.
  • Page 37 Follow the steps below to start from standby. Step Action Start Biacore X100 Control Software if it is not already running. In the login-dialog, enter your user name and password and click OK. Verify that the correct database connection is selected in the drop-down list.
  • Page 38 Make sure that there is fresh buffer or water in the bottle on the left-hand tray and that both buffer tubes are inserted into the bottle. Make sure that the waste bottle on the right-hand tray is empty and the waste tube is inserted in the bottle. Biacore X100 Operating Instructions 28961142 AF...

  • Page 39: Preparing, Loading And Changing Buffers

    If the instrument is equipped with the degasser provided with Biacore X100 Plus Package, you do not need to degas the water. Always use buffer, fresh for the day and filtered through a 0.22 µm filter to remove particles.

  • Page 40: Inserting A Sensor Chip

    Click the Undock chip icon, or select Undock Chip from the Tools menu. When undocking is completed, the Dock Chip dialog is displayed and the sensor chip lamp on the front flashes. Pull out the chip slide. If required, remove the old chip. Biacore X100 Operating Instructions 28961142 AF...
  • Page 41 Close the front door and check that the buffer tubes are placed in a bottle of buffer. Complete in the information in the Dock Chip dialog and click Dock Chip. The chip is docked and the standby flow of buffer over the chip starts automatically. Biacore X100 Operating Instructions 28961142 AF...

  • Page 42: Setting The Analysis Temperature

    The analysis temperature is fixed at 25°C in the standard instrument. With the optional Biacore X100 Plus Package, the analysis temperature can be set to 4°C to 40°C (maximum 10°C below ambient temperature).

  • Page 43: Preparing And Loading Samples And Reagents

    Prepare the samples and reagents in 1.5 mL conical vials (available from Cytiva) according to the volumes and concentrations in the rack position list. Make sure there are no visible air bubbles in the tubes. Cap the vials to avoid evaporation during the run.
  • Page 44 5 Operation 5.6 Preparing and loading samples and reagents Step Action Insert the rack in the sample compartment and make sure it sits properly on the rack base. Click OK in the Load Samples dialog. Biacore X100 Operating Instructions 28961142 AF...

  • Page 45: Starting A Run

    Starting a run Runs are programmed and started from a workflow, an application wizard or via a manual run. Details of how to program a run may be found in the Biacore X100 Hand- book and in the integrated software support.

  • Page 46: Post-Run Procedures

    Prepare the system for standby. used within 7 days If the instrument will Perform a shutdown. not be used for more than 7 days Section 6.7 Storage, on page 59 for details of these procedures. Biacore X100 Operating Instructions 28961142 AF...

  • Page 47: Maintenance

    All service and repairs, with the exception of operations explicitly described in the user documentation, must be carried out by personnel authorized by Cytiva. Do not open any covers or replace any parts unless specifically stated in the user documentation.
  • Page 48 6 Maintenance In this chapter Section See page Maintenance preparations Maintenance summary Cleaning Component maintenance Replacing the mains fuses Calibration Storage Biacore X100 Operating Instructions 28961142 AF...

  • Page 49: Maintenance Preparations

    Make sure that the BIAmaintenance Kit is available before starting maintenance procedures. Regular maintenance of Biacore X100 is essential for reliable results. It is important to keep the instrument free from contamination such as microbial growth and adsorbed proteins in the liquid handling system.

  • Page 50: Maintenance Summary

    For some applications, a coating of protein on the flow system walls helps to give reproducible results, and the first few cycles after Desorb may be unreliable. If you observe this behavior, run Desorb when you change your protein system rather than once a week. Biacore X100 Operating Instructions 28961142 AF...

  • Page 51: Cleaning

    Complete the checklist in the On Site Service Health and Safety Declaration Form or the Health and Safety Declaration Form for Product Return or Servicing, depending on whether the instrument is going to be serviced on site or returned for service, respec- tively. Biacore X100 Operating Instructions 28961142 AF...
  • Page 52 BIAdesorb solution 1 will precipitate at low temperature and should not be used at analysis or sample compartment temperatures below 20°C. To run Desorb below 20°C, replace BIAdesorb solution 1 with 0.5% lithium dodecyl sulfate in water. Biacore X100 Operating Instructions 28961142 AF...
  • Page 53 The procedure can either be run before immobilization or before the first run using the immobilized chip. Normalization injects BIAnormalizing solution (70% glyc- erol in water) over the chip surface. Required solutions: BIAnormalizing solution At the start of a run Biacore X100 Operating Instructions 28961142 AF...
  • Page 54 Run the maintenance tool Normalize to normalize the detector response for all flow cells. NOTICE Run Normalize with the sensor chip that will be used for the run. Do not use Sensor Chip Maintenance for this purpose. Biacore X100 Operating Instructions 28961142 AF...

  • Page 55: Component Maintenance

    Part Function Peristaltic pump Peristaltic pump tube fittings Degasser tube fittings (only included with Biacore X100 Plus Package) Syringe pump tube fittings Syringe pump Syringe pump barrel (below the plunger) Syringe pump plunger fitting Check system performance Run System check and pump calibration from the Tools →More Tools menu to...

  • Page 56: Replacing The Mains Fuses

    Follow the steps below to replace the mains fuses. Step Action Turn off the power to the Biacore X100 instrument. Disconnect the mains cord from the mains power inlet. Insert a small screwdriver under the tab on the fuse drawer cover.
  • Page 57 6 Maintenance 6.5 Replacing the mains fuses Step Action Replace both fuses. See the instrument product label for fuse ratings. Close the fuse drawer cover and reconnect the mains supply. Biacore X100 Operating Instructions 28961142 AF...

  • Page 58: Calibration

    The peristaltic pump is calibrated with the System check and pump calibration tool from the Tools →More Tools menu. Needle positioning is calbrated with the Replace needle tool from the Tools →More Tools menu. All other calibration of Biacore X100 is performed by Cytiva. Biacore X100 Operating Instructions 28961142 AF...

  • Page 59: Storage

    Leave the system in standby mode if it is to be used within the next 7 days. Biacore X100 is automatically placed in standby mode after the end of each run. In standby mode the instrument maintains a continuous low flow of buffer or water from the left hand bottle through the flow system to prevent accumulation of buffer resi- dues and to preserve the ligand on the chip.
  • Page 60 When instructed, open the lower front door and open the cover of the peri- staltic pump to release the clamping of the pump tube. Exit from Biacore X100 Control Software if it is still running. Remove the bottles, and the buffer bottle cap assembly. Clean the bottle trays if required.

  • Page 61: Troubleshooting

    Clean and maintain the instrument regularly as described in Chapter 6 Maintenance, on page 47. If you are experiencing problems that you cannot correct, contact your local service representative. In this chapter Section See page Instrument related problems Other problems Biacore X100 Operating Instructions 28961142 AF...

  • Page 62: Instrument Related Problems

    If the needle is damaged, check the following: Possible cause Action Unsuitable caps have been Ensure that only caps supplied by Cytiva are used used on the vials. to cap the 1.5 mL sample and reagent vials. Never cap the water vial.
  • Page 63 If any test failed, perform the action(s) according to the table below and then repeat the System Check and Pump Calibration. If the problem persists, contact your local Cytiva service representative. Use the table below to evaluate the results of the System check and pump calibra- tion procedure.
  • Page 64 Perform a System Check and Pump Calibration to calibrate the peristaltic pump. Samples become Not enough water to Always fill the water vial in the cross-contami- clean the injection rack before starting the run. nated. needle. Biacore X100 Operating Instructions 28961142 AF...
  • Page 65 • the instrument is not placed adjacent to heaters, cooling ducts, or in direct sunlight. Other instrument-related problems Unexpected detection results may appear if there are dust or other particles on the sensor chip surface. Never remove the sensor chip from its protective cassette. Biacore X100 Operating Instructions 28961142 AF...

  • Page 66: Other Problems

    Assay-related problems The Support Navigator in the software provides help on assay related problems. If you cannot solve your problems with the information provided, contact your local application support specialist. Biacore X100 Operating Instructions 28961142 AF...

  • Page 67: Reference Information

    8 Reference information Reference information About this chapter This chapter lists the technical specifications of Biacore X100. The chapter also includes a chemical resistance guide and Health and Safety Declaration forms for service. In this chapter Section See page Specifications...

  • Page 68: Specifications

    47 kg Supply voltage Autorange 100 to 240 V~, protective earthing Maximum voltage fluctuation ± 10% from the nominal voltage Frequency 50/60 Hz Fuses 2 × T4.0AH 250 V Maximum power consumption 400 VA Biacore X100 Operating Instructions 28961142 AF...
  • Page 69 Refer to the Biacore X100 data file. ments Note: Using a computer supplied by Cytiva is recommended. Refer to the Biacore X100 data file for information about Database included database and compatibility with other databases. Power requirements Refer to the manufacturer's instructions.

  • Page 70: Chemical Resistance

    Biacore X100 components. Regarding exposure to solutions not covered by these guidelines, contact your Cytiva representative for recommendations. The flow system and sensor chip are the only parts of Biacore X100 that come into contact with solutions. The guidelines in this section relate to tubing and connectors, selector valves, connector block, IFC and sensor chip.

  • Page 71: Recycling Information

    Waste batteries and accumulators must not be disposed of as unsorted municipal waste and must be collected separately. Follow applicable local regulations for recy- cling of batteries and accumulators. Biacore X100 contains a lithium backup battery, which must not be disposed of in fire. Biacore X100 Operating Instructions 28961142 AF...

  • Page 72: Regulatory Information

    8.4.1 Contact information 8.4.2 European Union and European Economic Area 8.4.3 Great Britain 8.4.4 Eurasian Economic Union (Евразийский экономический союз) 8.4.5 North America 8.4.6 China 8.4.7 General regulatory statements 8.4.8 Other regulations and standards Biacore X100 Operating Instructions 28961142 AF...

  • Page 73: Contact Information

    The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Cytiva Sweden AB Björkgatan 30 SE 751 84 Uppsala Sweden Telephone number of manufacturer + 46 771 400 600 Biacore X100 Operating Instructions 28961142 AF...

  • Page 74: European Union And European Economic Area

    • used according to the Operating Instructions or user manuals, and • used in the same state as it was delivered, except for alterations described in the Operating Instructions or user manuals. Biacore X100 Operating Instructions 28961142 AF...

  • Page 75: Great Britain

    • used according to the Operating Instructions or user manuals, and • used in the same state as it was delivered, except for alterations described in the Operating Instructions or user manuals. Biacore X100 Operating Instructions 28961142 AF...

  • Page 76: Eurasian Economic Union (Евразийский Экономический Союз)

    Telephone: +7 985 192 75 37 E-mail: rucis@cytiva.com Информация о производителе и импортере В следующей таблице приводится сводная информация о производителе и импортере, согласно требованиям Технических регламентов Таможенного союза и (или) Евразийского экономического союза. Biacore X100 Operating Instructions 28961142 AF...
  • Page 77 Member States of the Customs Union of the Eurasian Economic Union Данный знак о Евразийском соответствии указывает, что изделие одобрено для использования на рынках государств-членов Таможенного союза Евразийского экономического союза Biacore X100 Operating Instructions 28961142 AF...

  • Page 78: North America

    Note: The user is cautioned that any changes or modifications not expressly approved by Cytiva could void the user’s authority to operate the equip- ment. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.

  • Page 79: China

    有害物质声明 (DoHS) Declaration of Hazardous Substances (DoHS) 根据 SJ/T11364-2014《电子电气产品有害物质限制使用标识要求》特提供如下 有关污染控制方面的信息。 The following product pollution control information is provided according to SJ/ T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products. 电子信息产品污染控制标志说明 Biacore X100 Operating Instructions 28961142 AF...
  • Page 80 Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures. This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning. Biacore X100 Operating Instructions 28961142 AF...
  • Page 81 Indicates that this hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB/T 26572 • Data listed in the table represents best information available at the time of publication. Biacore X100 Operating Instructions 28961142 AF...

  • Page 82: General Regulatory Statements

    When used in a residential environment, there is a concern of radio interference. 유의사항 A급 기기 (업무용 방송통신 기자재) 이 기기는 업무용환경에서 사용할 목적으로 적합성평가를 받 은 기기 로서 가정용 환경에서 사용하는 경우 전파간섭의 우려가 있습 니다. Biacore X100 Operating Instructions 28961142 AF...

  • Page 83: Other Regulations And Standards

    This section describes the additional standards that apply to the product. Regulatory compliance of connected equipment Any electrical equipment connected to Biacore X100 shall meet the safety require- ments of EN/IEC 61010-1, or other relevant national safety regulations and standards. Within EU, connected equipment must be CE marked.

  • Page 84: Ordering Information

    8 Reference information 8.5 Ordering information Ordering information Ordering information for Biacore X100 and related products can be found on cytiva.com/biacore. Biacore X100 Operating Instructions 28961142 AF...

  • Page 85: Health And Safety Declaration Form

    Service Ticket #: To make the mutual protection and safety of Cytiva service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, complete this checklist and present it to the Service Engineer upon arrival.
  • Page 86 To make sure the mutual protection and safety of Cytiva personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to Cytiva. To avoid delays in the processing of your equipment, complete this checklist and include it with your return.

  • Page 87: Index

    Finish a run, 46 substances, 71 Flammable liquids, 11 Regulatory information, 72 Replacing fuses, 56 Important user information, 5 Inserting a sensor chip, 40 Instrument overview, 19 Safety, 9 precautions, 9 Instrument problems, 62 Biacore X100 Operating Instructions 28961142 AF...
  • Page 88 Start a run, 45 Starting the instrument, 36 Status indicators, 23 Storage conditions, 60 System check, 55, 63 Temperature control, 42, 65 Typographical conventions, 6 UK, 75 conformity, 75 UKCA, 75 marking, 75 Workflow, 35 Biacore X100 Operating Instructions 28961142 AF...
  • Page 89 Page intentionally left blank...
  • Page 90 QR code. cytiva.com/biacore Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp. or an affiliate doing business as Cytiva. Biacore is a trademark of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.

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